(169 days)
No
The summary describes the software as performing calculations and displaying data, but there is no mention of AI, ML, or any related concepts like training or test sets for model development. The performance studies focus on software functionality and integration, not model performance metrics.
No.
The device is a software accessory that retrieves, analyzes, and displays data. It does not provide any therapy or treatment.
Yes
Explanation: The device "retrieves, analyzes, and displays Cerebral Blood Flow velocity (CBFv) data" and "uses CBFv data to measure the variability of a patient's cerebral blood flow velocity." This analysis and measurement of physiological data to provide information for clinical decision-making, particularly in managing head trauma, aligns with the definition of a diagnostic device.
Yes
The device is described as a "stand-alone software accessory" that retrieves, analyzes, and displays data from a separate hardware device (Transcranial Doppler Ultrasound). The description focuses solely on the software's functions and testing, with no mention of hardware components included with the Varia-NCI itself.
Based on the provided information, Varia-NCI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Varia-NCI's Function: Varia-NCI analyzes and displays data obtained from a Transcranial Doppler Ultrasound device. This data is derived from the physical measurement of blood flow velocity within the brain, not from the analysis of a biological specimen taken from the body.
- Input Modality: The input is Transcranial Doppler Ultrasound, which is an imaging modality, not a method for analyzing biological samples.
Therefore, Varia-NCI falls under the category of a medical device that processes and analyzes physiological data obtained through an imaging technique, rather than an IVD device that analyzes biological specimens.
N/A
Intended Use / Indications for Use
Varia-NCI is a stand-alone software accessory to a Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, and displays Cerebral Blood Flow velocity (CBFv) data from a Transcranial Doppler Ultrasound device. Varia-NCI uses CBFv data to measure the variability of a patient's cerebral blood flow velocity.
Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.
Product codes
IYN
Device Description
Varia-NCI accesses data from Compumedics Germany QL 3.0 software. QL 3.0 is a trade mark of PC-based software supplied by Compumedics Germany, GmbH and included with their digital Transcranial Doppler (TCD) Ultrasound device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Transcranial Doppler Ultrasound (TCD)
Anatomical Site
Cerebral (specifically cerebral blood flow velocity)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A test report was generated consisting of Test Description, Test Date, Tester Name, Test Criteria, Test Setup, Pass Fail Criteria, and Test Data Files. The report indicates that the software passed the test.
The following software testing has been performed to support substantial equivalence:
- System Integration Multiprocessing testing : Test Passed
- . System Integration - Timing and Memory Allocation : Test Passed
- User Interface Module : Test Passed
- Single Patient Module Patient information needs to be displayed.
- User interface needs to display CBFv variability values and chart
- The system needs to export results in csv format
- Patient Data testing
- CBFv exp files were entered into the database
- Patient name was entered into the database
- . Patient was recalled and verified that the data was the correct file
- Calculation Testing and Display results : Test Passed
- The variability of CBFv was calculated and displayed as numeric value and as a chart
- Save results Testing : Test Passed
- Test results were successfully saved using Save button
- System Verification/Validation Performance Testing : Test Passed
- Labeling - User Manual Verification/Validation : Test Passed
- Manufacturing : Test Passed
- Verify that all manufacturing documentation is released
- All software files checked into VNS Software repository
- Ran through the software build process and built the package on a clean machine with Delphi XE2 installed.
- Installed libraries as directed in Build Process
- . Installed
- -ExpressQuantumGrid
- -ExpressBars
- -ExpressNavBar
- -DBSAM
- Installed application software
- . Run Delphi and Install supplied
- application libraries Hyperclass,
HyperDSP, ECG, and Miracle:
- Open Menu: File/Open... Name of the libraryD7.dpk
- Compiled Software
- Reviewed BOM and Software Package
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: A test report was generated consisting of Test Description, Test Date, Tester Name, Test Criteria, Test Setup, Pass Fail Criteria, and Test Data Files. The report indicates that the software passed the test.
Clinical Performance Data: No clinical testing is required because the device's indication for use does not substantiate the need for clinical data to support equivalency to the predicate device. The predicate device has been on the market for nearly 10 years with proven safety and effectiveness. The non-clinical testing detailed in this submission confirms the safety and effectiveness of the Varia-NCI.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that overlap and create a sense of movement.
November 19, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NeuroChaos Solutions, Inc. % Ms. Elisa Maldonado-Holmertz Consultant Obelix Consulting, LLC 12416 Fairfax Ridge Place AUSTIN TX 78738
Re: K141462 Trade/Device Name: Varia-NCI Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN Dated: October 16, 2014 Received: October 21, 2014
Dear Ms. Maldonado-Holmertz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141462
Device Name
Varia-NCI
Indications for Use (Describe)
Varia-NCI is a stand-alone software accessory to a Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, and displays Cerebral Blood Flow velocity (CBFv) data from a Transcranial Doppler Ultrasound device. Varia-NCI uses CBFv data to measure the variability of a patient's cerebral blood flow velocity.
Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.
Type of Use (Select one or both, as applicable)
XPrescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for NeuroChaos Solutions. The logo features a stylized, abstract graphic to the left of the company name. The text "NeuroChaos" is in a bold, sans-serif font, with the word "SOLUTIONS" appearing in smaller letters below it.
Section 5 – 510(k) Cover Letter
510(k) Summary
Varia-NCI
1. Submission Sponsor
NeuroChaos Solutions, Inc. 2645 Creeks Edge Parkway Austin, TX 78733 USA Contact: Patrick Kothe, CEO Phone: 512.426.5772 Email: pkothe@neurochaos.com
2. Submission Correspondent
Obelix Consulting, LLC 12416 Fairfax Ridge Place Austin, TX 78738 USA Contact: Elisa Maldonado-Holmertz, Consultant Phone: 512.431.6069 Email: elisamh@obelixconsult.com
3. Date Prepared
30 May 2014
4. Device Identification
| Trade/Proprietary Name: | NeuroChaos Solutions, System 1.0 |
|---|---|
| Common/Usual Name: | Accessory to Transcranial Doppler |
| Classification Name: | Ultrasonic pulsed Doppler imaging system |
| Classification Regulation: | CRF 892.1550 |
| Product Code: | IYN |
| Device Class: | Class II |
| Classification Panel: | Radiology |
5. Legally Marketed Predicate Device(s)
Compumedics Germany – Doppler-Box X (K051085)
4
Image /page/4/Picture/0 description: The image shows the logo for NeuroChaos Solutions. The logo consists of a stylized, abstract symbol to the left of the text "NeuroChaos" in a bold, sans-serif font. Below "NeuroChaos" is the word "SOLUTIONS" in a smaller, lighter font. The overall design is clean and professional.
6. Device Description
Varia-NCI accesses data from Compumedics Germany QL 3.0 software. QL 3.0 is a trade mark of PC-based software supplied by Compumedics Germany, GmbH and included with their digital Transcranial Doppler (TCD) Ultrasound device.
7. Indication for Use Statement
Varia-NCI is an accessory to a Transcranial Doppler Ultrasound device (TCD) that collects, analyzes, stores, and displays Cerebral Blood Flow velocity (CBFv) data. Varia-NCl uses CBFv data to measure the variability of a patient's cerebral blood flow velocity.
Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.
8. Substantial Equivalence Discussion
The following table compares the Varia-NCI to the predicate device with respect to indications for use, intended use, and principles of operation for the determination of substantial equivalence.
| Manufacturer | NeuroChaos Solutions, Inc. | Compumedics Germany, GmbH |
|---|---|---|
| Trade Name | Varia-NCI | Doppler-Box X |
| 510(k) Number | -- | K051085 |
| Product Code | IYN | IYN and ITX |
| Regulation Number | 892.1550 | 892.1550 |
| 892.1570 | ||
| Regulation Name | Ultrasonic pulsed Doppler imaging system | Ultrasonic pulsed Doppler imaging system |
| Indications for Use | Varia-NCI is a stand-alone software accessory to a | |
| Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, stores, and displays | ||
| Cerebral Blood Flow velocity (CBFv) data from a Transcranial | ||
| Doppler Ultrasound device. | ||
| Varia-NCI uses CBFv data to measure the variability of a | ||
| patient's cerebral blood flow velocity. |
Vari-NCI is to be used by
clinicians managing head trauma | The Doppler-Box is a medical
ultrasound device for measuring
the blood flow velocities in arteries
and veins mainly subcutaneously.
The 16MHz probe can also be used
intraoperative. |
Table 5A - Comparison of Characteristics
5
| Manufacturer | NeuroChaos Solutions, Inc.
in the ICU, Surgical Unit,
Emergency Department, and
Clinical and Sports Medicine
Settings. | Compumedics Germany, GmbH |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate | Compumedics Germany GmbH
Doppler-Box X | Spencer Technologies; TCD 100M,
PWD13 TRANSDUCER K002533
CompumedicsDWL Elektronische
Systeme GmbH; Multi-Dop X
K931801 |
| Significant
Differences | Stand-alone software accessory
to a Transcranial Doppler | Digital Doppler sonography system.
HD resolution in Doppler M-Mode
permits more precise insonation.
The innovative hardware design
with no integrated computer, but
with the possibility to connect to all
standard Windows©-based
computer systems |
9. Non-Clinical Performance Data
A test report was generated consisting of Test Description, Test Date, Tester Name, Test Criteria, Test Setup, Pass Fail Criteria, and Test Data Files. The report indicates that the software passed the test.
The following software testing has been performed to support substantial equivalence:
- System Integration Multiprocessing testing : Test Passed ●
- . System Integration - Timing and Memory Allocation : Test Passed
- User Interface Module : Test Passed ●
- Single Patient Module Patient information needs to be displayed. O
- O User interface needs to display CBFv variability values and chart
- The system needs to export results in csv format O
- Patient Data testing o
- CBFv exp files were entered into the database
- Patient name was entered into the database
- . Patient was recalled and verified that the data was the correct file
- Calculation Testing and Display results : Test Passed
- The variability of CBFv was calculated and displayed as o numeric value and as a chart
- Save results Testing : Test Passed
- Test results were successfully saved using Save button O
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Image /page/6/Picture/0 description: The image contains the logo for NeuroChaos Solutions. The logo features a stylized graphic to the left of the company name. The text "NeuroChaos" is in a bold, sans-serif font, with the word "SOLUTIONS" appearing in a smaller font size below it.
- System Verification/Validation Performance Testing : Test Passed ●
- Labeling - User Manual Verification/Validation : Test Passed
- Manufacturing : Test Passed
- o Verify that all manufacturing documentation is released
- o All software files checked into VNS Software repository
- o Ran through the software build process and built the package on a clean machine with Delphi XE2 installed.
- l Installed libraries as directed in Build Process
- . Installed
- -ExpressQuantumGrid
- -ExpressBars
- -ExpressNavBar
- -DBSAM
- Installed application software
- . Run Delphi and Install supplied
- application libraries Hyperclass,
HyperDSP, ECG, and Miracle:
- Open Menu: File/Open... Name of the libraryD7.dpk
- Compiled Software
- Reviewed BOM and Software Package
Varia-NCI is not required to conduct sterilization, biocompatibility, or electrical testing as a standalone software accessory.
As part of demonstrating safety and effectiveness, Varia-NCI shows substantial equivalence as an accessory to the predicate device that is subject to this 510(k) submission. Varia-NCI complies with the applicable Software standards.
10. Clinical Performance Data
No clinical testing is required because the device's indication for use does not substantiate the need for clinical data to support equivalency to the predicate device. The predicate device has been on the market for nearly 10 years with proven safety and effectiveness. The non-clinical testing detailed in this submission confirms the safety and effectiveness of the Varia-NCI.
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Image /page/7/Picture/0 description: The image shows the logo for NeuroChaos Solutions. The logo features a stylized, abstract graphic to the left of the text. The text "NeuroChaos" is in a bold, sans-serif font, with the word "SOLUTIONS" in a smaller font size underneath. The colors used in the logo are shades of blue.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same operational characteristics as the previously cleared predicate device, or the device has the same intended use and different operational characteristics in which substantial equivalency can be demonstrated in the device in comparison to the predicate device. Additionally, the new device does not raise new questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the difference between Varia-NCI and the predicate device does not raise any questions regarding its safety and effectiveness. Varia-NCI, as designed and produced, is determined to be substantially equivalent as an accessory to the referenced predicate device.